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Completed

NCT Number: NCT06677957

A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Resistance Protein in Healthy Participants

This is a Phase 1, open-label, two-period, one-sequence, crossover drug-drug interaction study to assess the P-gp and BCRP inhibition potential of divarasib using digoxin and rosuvastatin as probe substrates, respectively, in healthy participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Daytona Beach Clinical Rsch Unit

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females of non-childbearing potential
  • Within body mass index (BMI) range of 18.0 to 32.0 kg/m2, inclusive

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal (GI), neurological, or psychiatric disorder
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
  • Poor peripheral venous access

Treatment and study plan

Digoxin

Drug

Digoxin will be administered together with Rosuvastatin as a drug cocktail as specified for the respective period

Divarasib

Drug

Divarasib will be administered in combination with Digoxin and Rosuvastatin as specified for the respective period

Rosuvastatin

Drug

Rosuvastatin will be administered together with Digoxin as a drug cocktail as specified for the respective period

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Digoxin and Rosuvastatin

    Time frame: Day 1 of Period 1 and Day 5 of Period 2

  2. Area Under the Plasma Concentration-Time Curve from Hour 0 to the Last Measurable Concentration (AUC0-t) of Digoxin and Rosuvastatin

    Time frame: Day 1 of Period 1 and Day 5 of Period 2

  3. Area Under the Plasma Concentration-Time Curve (AUC0-inf) of Digoxin and Rosuvastatin

    Time frame: Day 1 of Period 1 and Day 5 of Period 2

  4. Time to Cmax (Tmax) of Digoxin and Rosuvastatin

    Time frame: Day 1 of Period 1 and Day 5 of Period 2

Secondary outcomes

  1. Percentage of Participants with Adverse Events (AEs)

    Time frame: From Day 1 until end of study participation (approximately 2 months)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase I, Open-Label, Two-Period, One-Sequence, Crossover Study in Healthy Subjects to Evaluate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein (Digoxin) and Breast Cancer Resistance Protein (Rosuvastatin)

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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